Selexis SA and Turgut Pharmaceuticals Advance Partnership with Third Commercial License Agreement

Press Release

December 20, 2017

Selexis SA and Turgut Pharmaceuticals Advance Partnership with Third Commercial License Agreement

Supports Advancement of Biosimilar to Treat Two Ultra-Rare Diseases

Geneva, Switzerland, and Istanbul, Turkey, 20 December 2017 – Selexis SA and Turgut Pharmaceuticals (Turgut Ilaclari A.S.) announced today that they have entered into a third commercial license agreement that provides Turgut with access to Selexis SUREtechnology Platform™ and SURE CHO-M Cell Line™ for the development of a high-quality biosimilar product for the treatment of two ultra-rare diseases: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The new agreement builds on two commercial license agreements established between the companies in July 2016 to develop biosimilar products to treat inflammatory diseases and certain cancers using the SURE CHO-M Cell Lines.

“At Selexis, we value our role in contributing to the success of partners like Turgut Pharmaceuticals who are working to bring additional therapeutic options to patients who are facing complex, and sometimes life-threatening, diseases,” said Marco Bocci, PhD, DPharm, Selexis vice president, licensing and business development. “Based on biosimilarity data from the two previous projects, this newly signed commercial license agreement is a testament of the predictability of the SUREtechnology Platform and cell line when applied to development of biosimilars.”

Selexis’ proprietary SUREtechnology Platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein, including biosimilars, and provides seamless integration of the biologics development continuum, spanning discovery to commercialization. Often, the biggest challenge with CHO-generated biosimilar products is ensuring enough similarity in glycan profile to the originator. Utilizing the SUREtechnology Platform, Selexis has successfully generated numerous biosimilars, including marketed products, that have glycan profiles matching originator products. Data supplied by Turgut Pharmaceuticals in Figure 1 is a representative comparative glycan profile of one of the biosimilar candidates being developed under the Selexis and Turgut Pharmaceuticals partnership.

N-glycan profile

FIGURE 1 Comparison of the N-glycan profiles – Innovator vs. Biosimilar: N-glycans profiles determined by liquid chromatography coupled fluorescent detection demonstrate that the glycan profile of a Turgut Pharmaceuticals biosimilar monoclonal antibody (mAb) candidate expressed by the Selexis SUREtechnology Platform™-generated manufacturing cell line completely aligns with innovator mAb drug.

Serdar Alpan, MD, PhD, Head of Biotechnology Group, Turgut Pharmaceuticals stated that, after two successful biosimilar monoclonal antibody development projects, Turgut Pharmaceuticals’ global standard biotechnology platform is now starting the development of the third biosimilar monoclonal antibody. “Our collaboration with Selexis and its SUREtechnology Platform is an important component of our established biotechnology platform and we are expecting to extend our collaboration with new industrial cell line developments,” he said.

The Selexis SURE CHO-M Cell Line is a proprietary high-performance mammalian cell line that is derived from CHO-K1 cells and used for the production of therapeutic recombinant proteins and monoclonal antibodies. The growth and production properties of the Selexis SURE CHO-M Cell Line are well defined, and the feed strategy has been optimized, allowing for faster and more efficient scale-up to bioreactors. Therapeutics that are generated using Selexis SURE CHO-M cells are in both clinical trials and marketed products.

PNH is a condition where red blood cells are created without a protective protein, which causes them to burst. The disease is characterized by destruction of red blood cells, thrombosis, and impaired bone marrow function.

aHUS is a rare, life-threatening, genetic disease that can damage vital organs such as the kidneys, heart, and brain. In patients with aHUS, blood clots form in small blood vessels throughout the body, a process known as systemic thrombotic microangiopathy, or TMA.

About Selexis SA
Selexis SA is a pioneering life sciences company and a global leader in mammalian (suspension-adapted CHO-K1) cell line generation, providing unparalleled proprietary technology and the highly-specialized expertise that is necessary to translate scientific innovation into life-saving medicines for patients. Selexis’ SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein and provides seamless integration of the bioproduction continuum, spanning discovery to commercialization. With more than 100 partners worldwide, 85 drug products in clinical development and three commercial products utilizing Selexis-generated cell lines, the Company has a history of empowering scientists and biopharmaceutical companies around the world to realize the full potential of their research. More information is available at www.selexis.com.

About Turgut Pharmaceuticals
Turgut Group, with over 50 years’ experience, is one of the major entrepreneurs of the Turkish pharmaceutical industry. The group has recently incorporated its pharmaceutical activities under the roof of Turgut Pharmaceuticals, with a focus on biotechnology. With its global collaborations, established development platform and global standard GMP biotechnology manufacturing facility under construction, Turgut Pharmaceuticals is the leading biotech company in Turkey with the vision to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States.

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FOR MORE INFORMATION
– Web www.selexis.com
– LinkedIn www.linkedin.com/company/selexis-sa
– Twitter www.twitter.com/SelexisSA
– Facebook www.facebook.com/SelexisSA
Turgut Pharmaceuticals LinkedIn page: www.linkedin.com/company/10116105/

Media Inquiries for Selexis
Mike Beyer
Sam Brown Inc.
+1 312-961-2502
mikebeyer@sambrown.com

Company Inquiries for Selexis
Robert Meister
Head, Corporate Communications
+1 602-953-1716
robert.meister@selexis.com

Company Inquiries for Turgut Pharmaceuticals
Serdar Recep Alpan
Head of Biotechnology Group
+902122801251
salpan@turgutilac.com.tr